Apparatus and method for sealing a vascular puncture

ABSTRACT

Closure devices for sealing a puncture and methods of sealing a puncture are described herein. A closure device may be used to position a sealant in a puncture. The sealant may be provided in a sheath which is retracted to expose the sealant in the puncture. A support member may be advanced to compress the sealant. The device may have a lock that prevents the support member from advancing prematurely. The lock may be unlocked when the sheath is at least partially retracted. The device may have an actuator that controls movement of the sheath and the support member. The lock may remain in a locked position until the sheath is at least partially retracted.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/623,350, entitled “APPARATUS AND METHOD FOR SEALING AVASCULAR PUNCTURE” and filed on Jan. 20, 2018, which is incorporatedherein by reference in its entirety.

FIELD

Devices and methods described herein may be useful for sealing avascular puncture using a plug or sealant.

BACKGROUND

Some diagnostic or therapeutic procedures require access to a patient'svasculature (e.g., imaging procedure, angioplasty, stent delivery, orotherwise). A puncture through the patient's tissue may be created toaccess the patient's vasculature percutaneously, i.e., a puncture may becreated through the tissue. After completion of the diagnostic ortherapeutic procedure, the puncture can be closed by various mechanicalor biological solutions, such as by applying external pressure (e.g.,manually and/or using sandbags), cinching, suturing, and/or deliveringmetal implants, plugs, or sealants. However, many of these closureprocedures may be time consuming, expensive, and uncomfortable for thepatient, requiring the patient to remain immobilized in the operatingroom, catheter lab, or holding area for extended periods of time.Additionally, some of these prolonged closure procedures may increasethe risk of hematoma from bleeding prior to hemostasis.

When closing the puncture using a metal implant, plug, sealant, or otherappropriate sealing member, the health care professional may use avascular closure device to position and deploy the sealing member. Thedevice may include a sheath and a support member. The sealant may bepositioned inside a sheath or other protective member. The sheath may bemoved proximally to expose the sealant in the puncture. The supportmember may be moved distally to tamp the sealant. However, tamping thesealant prematurely may cause the sealant to become jammed in thesheath.

SUMMARY

The devices described herein may be used to deploy a sealant in apuncture. These devices may include a sealant sleeve and a supportmember. During normal operation of the device, the sealant may beinitially positioned in a protective member, such as a sealant sleeve.The sealant sleeve may be withdrawn to expose the sealant within thepuncture. The support member may be advanced to compress the sealant. Itis preferable that at least a portion of the sealant be exposed withinthe puncture prior to advancing the support member to prevent thesealant from becoming jammed.

The devices described herein may include a handle containing a pull rackand a push rack. The sealant sleeve may extend distally from the pullrack. The support member may be a tube, and may extend distally from thepush rack. The pull rack and the push rack may interact with othercomponents of the device to control movement of the sealant sleeve andsupport member.

The devices described herein may include a releasable lock to preventpremature advancement of the support member, while allowing advancementof the support member after the sealant has been at least partiallyexposed. It may be beneficial to decouple distal movement of the supportmember and disengagement of the lock, such that a distal force appliedto the support member does not disengage the lock. For example, in someembodiments, proximal movement of the sealant sleeve may release thelock, thereby allowing the support member to move distally.

Another benefit of the devices described herein is their ability toprovide a smooth force transition as the lock is disengaged. If the userexperiences a sudden increase in force when disengaging the lock, theuser may mistakenly believe that they have fully actuated an actuatorassociated with the sealant sleeve and/or support member, when they mayjust be experiencing an activation force to disengage the lock from thepush rack and/or support member.

Another benefit of the devices described herein is the ability to designthe device to expose a desired percentage of the sealant before the lockis released, and continue to control the additional distance and ratethat the sleeve retracts as the support member is advanced to tamp thesealant.

Another benefit of the devices described herein is that the supportmember and push rack may be substantially unbiased relative to thesealant. In other words, the device does not need a spring to bias thepush rack distally. Therefore, disengaging the push rack lock does notnecessarily cause the push rack to move distally toward the sealant. Anactuator may control distal movement of the push rack, which allows theuser to have more control over the timing and speed of advancement ofthe push rack. In addition, the push rack lock may maintain a lockedposition, even if the push rack is not biased toward the push rack lock.

DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of a device for delivering a sealant.

FIG. 2A is a perspective view of a pull rack, sealant sleeve, andconnector of the device of FIG. 1.

FIG. 2B is a side view of the pull rack, sealant sleeve, and connectorof FIG. 2A.

FIG. 3 is a perspective view of a push rack and support member of thedevice of FIG. 1.

FIG. 4A is a perspective of a frame of the device of FIG. 1.

FIG. 4B is a top view of the frame of FIG. 4A.

FIG. 4C is a cross-sectional view of the frame of FIG. 4A.

FIG. 5A is a top view of the device of FIG. 1 in a locatingconfiguration (the deployment actuator, sheath adapter, and half of theouter housing are not shown).

FIG. 5B is a side view of the device of FIG. 1 in a locatingconfiguration (the sheath adapter and half of the outer housing are notshown).

FIG. 5C is a cross-sectional view of the distal section of the device ofFIG. 1 in a locating configuration.

FIG. 5D is a cross-sectional view of the distal section of the device ofFIG. 1 in a locating configuration, showing an embodiment of a sealanthaving a proximal section and a distal section.

FIG. 6A is a top view of the device of FIG. 1 in a pre-deploymentconfiguration (the deployment actuator, sheath adapter, and half of theouter housing are not shown).

FIG. 6B is a side view of the device of FIG. 1 in a pre-deploymentconfiguration (the sheath adapter and half of the outer housing are notshown).

FIG. 6C is a cross-sectional view of the distal section of the device ofFIG. 1 in a pre-deployment configuration.

FIG. 7A is a top view of the device of FIG. 1 in a partially deployedconfiguration (the deployment actuator, sheath adapter, and half of theouter housing are not shown).

FIG. 7B is a side view of the device of FIG. 1 in a partially deployedconfiguration (the sheath adapter and half of the outer housing are notshown).

FIG. 7C is a cross-sectional view of the distal section of the device ofFIG. 1 in a partially deployed configuration.

FIG. 8A is a top view of the device of FIG. 1 in a fully deployedconfiguration (the deployment actuator, sheath adapter, and half of theouter housing are not shown).

FIG. 8B is a side view of the device of FIG. 1 in a fully deployedconfiguration (the sheath adapter and half of the outer housing are notshown).

FIG. 8C is a cross-sectional view of the distal section of the device ofFIG. 1 in a fully deployed configuration.

FIG. 9 is a perspective view of a deployment actuator of the device ofFIG. 1.

FIG. 10 is a perspective view of the device of FIG. 1 (the outer housingand frame are not shown).

DETAILED DESCRIPTION

A closure system 1 is illustrated in FIGS. 1 and 5A-8C. The closuresystem 1 may comprise a sealant 2 and a device 100 for delivering thesealant 2. The device 100 may comprise a pull rack 120 and a push rack140 slidably positioned in an outer housing 112 (also referred to as ahandle). The device 100 may also comprise a frame 114 slidablypositioned in the outer housing 112. A sealant sleeve 130 may extenddistally from the pull rack 120. A support member 150 may extenddistally from the push rack 140. The support member 150 may be insertedinto the sealant sleeve 130. The sealant 2 may be positioned in thesealant sleeve 130, distal to the support member 150. The device 100 mayinclude a deployment actuator 170 that, when depressed or otherwiseactuated, exposes and/or tamps the sealant 2. The device 100 may includea sheath adapter 106 that allows the device to interface with aprocedural sheath. The device 100 may include an elongate member 102 andpositioning element 104 to position the device 100 before exposing thesealant 2. The device 100 may also include a retraction actuator 180that retracts the positioning element 104 and the elongate member 102relative to the support member 150 to withdraw the positioning element104 and the elongate member 102 through the sealant 2. The device 100may include various features (described below) to prevent unintendedmovement of the outer housing 112, deployment actuator 170, retractionactuator 180, pull rack 120, push rack 140, and/or frame 114 relative toone another or relative to other components in the device 100.

The device 100 may include a pull rack 120 and a sealant sleeve 130,shown in FIGS. 2A-2B. The sealant sleeve 130 may be a tubular memberhaving a proximal section 131, a distal section 132, and a lumen 133.The sealant sleeve 130 may extend along the longitudinal axis 3 of thedevice 100 as shown in FIG. 1. The sealant 2 may be positioned in thelumen 133 of the sealant sleeve 130, preferably in the distal section132. The distal section 132 of the sealant sleeve 130 may be rounded ortapered at the distal end to enclose the sealant 2. The proximal section131 of the sealant sleeve 130 may be coupled to the pull rack 120, suchthat when the pull rack 120 moves proximally away from the sealant 2,the sealant sleeve 130 also moves proximally, thereby exposing thesealant 2. In one exemplary embodiment, FIGS. 2A-2B show the sealantsleeve 130 indirectly coupled to the pull rack 120 using a connector138. However, the pull rack 120 and sealant sleeve 130 may be integrallyformed, directly coupled, or indirectly coupled using various techniquesknown in the art. The pull rack 120 may be slidably positioned in theouter housing 112. The pull rack 120 may have an actuating feature 121(shown as an actuating groove 121 in FIGS. 2A-2B) that is engageablewith the deployment actuator 170 (described below) and a push rack lockunlocking feature 123 (shown as a wall 123 protruding from the pull rack120 in FIGS. 2A-2B) that is engageable with the push rack lock 160(described below).

The device 100 may include a push rack 140 and a support member 150,shown in FIG. 3. The support member 150 may be a tubular member (and maybe referred to as a tamp tube or tamping member). The support member 150having a proximal section 151, a distal section 152, and a lumen 153.The support member 150 may extend along the longitudinal axis 3 of thedevice 100 as shown in FIG. 1. The distal section 152 of the supportmember 150 may be slidably positioned in the lumen 133 of the sealantsleeve 130, proximal to the sealant 2. The support member 150 mayprevent the sealant 2 from moving proximally when the sealant sleeve 130is withdrawn. The proximal section 151 of the support member 150 may becoupled to the push rack 140, such that when the push rack 140 movesdistally toward the sealant 2, the support member 150 also movesdistally, thereby tamping or compressing the sealant 2. In an exemplaryembodiment, FIG. 3 shows the push rack 140 directly coupled to thesupport member 150. However, the push rack 140 and support member 150may be integrally formed, directly coupled, or indirectly coupled usingvarious techniques known in the art. The push rack 140 may be slidablypositioned in the outer housing 112. The push rack 140 may have anactuating feature 143 (shown as an actuating ramp 143 in FIG. 3) that isengageable with the deployment actuator 170 and a push rack lockengaging feature 144 (shown as a latch-contacting surface 144 in FIG. 3)that is engageable with the push rack lock 160 (described below). Thepush rack lock engaging feature 144 may have a distal-facing surfacethat engages with the push rack lock 160.

The device 100 may include a deployment actuator 170, shown in FIG. 9.The deployment actuator 170 may be actuatable to move the pull rack 120(and sealant sleeve 130) proximally and/or move the push rack 140 (andsupport member 150) distally. The deployment actuator 170 may have alocked position, an unlocked position, a partially actuated position,and a fully actuated position. The deployment actuator 170 may becoupled to the outer housing 112 such that axial movement of the outerhousing 112 results in axial movement of the deployment actuator 170.The deployment actuator 170 may be movable relative to the outer housing112 upon actuation.

The device 100 may include a frame 114, as shown in FIGS. 4A-4C. Theframe 114 (also referred to as an inner frame) may be positioned inside,and axially movable relative to, the outer housing 112. The frame 114may initially engage the pull rack 120 and push rack 140 such thatmoving the outer housing 112 proximally relative to the frame 114 alsomoves outer housing 112 proximally relative to the pull rack 120 andpush rack 140. A spring 101, shown in FIG. 5B, may be provided in thedevice 100 to apply a biasing force that biases the frame 114 proximallyrelative to the outer housing 112 and the deployment actuator 170, andtherefore the spring 101 also applies a biasing force that biases theouter housing 112 and the deployment actuator 170 distally relative tothe frame 114. The frame 114 may include a deployment feature 115 (forexample, a slot or a groove) which may be engageable with a portion ofthe deployment actuator 170.

The deployment actuator 170 is shown as a depressible button in FIG. 9,but may alternatively be a slidable button, a lever, a rotating knob, awheel, or any other actuator that is capable of moving the pull rack 120proximally and the push rack 140 distally. The deployment actuator 170may have an actuator locking surface 171 that selectively prevents (orallows) actuation of the deployment actuator 170. In FIG. 9, theactuator locking surface 171 is shown as a pin, but it can be anyprotrusion or other feature that selectively engages a groove 115 in theframe 114 to selectively allow (or prevent) actuation of the deploymentactuator 170. The deployment actuator 170 may have a pull rack actuatingsurface 172 that drives the pull rack 120 proximally. In FIG. 9, thepull rack actuating surface 172 is shown as a pin that selectivelyengages a groove 121 in the pull rack 120 to move the pull rack 120proximally. The deployment actuator 170 may have a push rack actuatingsurface 173 that drives the push rack 140 distally. In FIG. 9, the pushrack actuating surface 173 is shown as a wall that selectively engagesthe actuating ramp 143 on the push rack 140 to move the push rack 140distally.

The deployment actuator 170 may be provided in the locked position,shown in FIG. 5B, in which actuation of the deployment actuator 170 isprevented. The deployment actuator 170 may contact the frame 114 toprevent actuation. More specifically, the actuator locking surface 171may rest on a surface of the frame 114 (in other words, the actuatorlocking surface 171 may be offset from the groove 115 in the frame 114),thereby preventing the user from actuating the deployment actuator 170.The push rack actuating surface 173 of the deployment actuator 170 maybe spaced from the actuating ramp 143 on the push rack.

When the deployment actuator 170 is in the unlocked position, shown inFIG. 6B, the deployment actuator 170 may be actuatable. The deploymentactuator 170 may be moveable relative to the frame 114. Morespecifically, the actuator locking surface 171 may be positioned at anopening of, and may align with, the groove 115 in the frame 114 to allowactuation of the deployment actuator 170. The push rack actuatingsurface 173 of the deployment actuator 170 may be spaced from theactuating ramp 143 on the push rack. Compared to their respectivepositions when the deployment actuator 170 is in the locked position,the outer housing 112 and deployment actuator 170 may be positionedslightly proximally relative to the frame 114, pull rack 120, and pushrack 140 when the deployment actuator 170 is in the unlocked position.

When the deployment actuator 170 is in the partially actuated position(also referred to as a partially depressed position), shown in FIG. 7B,the actuator locking surface 171 may be positioned in the groove 115 inthe frame 114. The push rack actuating surface 173 of the deploymentactuator 170 may be in contact with the actuating ramp 143 on the pushrack 140. As the deployment actuator 170 is actuated, the actuatorlocking surface 171 may move along the groove 115 in the frame 114.

When the deployment actuator 170 is in the fully actuated position (alsoreferred to as a fully depressed position), shown in FIG. 8B, theactuator locking surface 171 may be positioned in the groove 115 in theframe 114. When the deployment actuator 170 is in the fully actuatedposition, the actuator locking surface 171 may be positioned fartherfrom the opening in the groove 115 in the frame 114 compared to itsposition when the deployment actuator 170 is in the partially actuatedposition. The push rack actuating surface 173 of the deployment actuator170 may be in contact with the actuating ramp 143 on the push rack 140,and the push rack actuating surface 173 may be positioned farther downthe ramp 143 on the push rack 140 compared to its position when thedeployment actuator 170 is in the partially actuated position.

The device 100 may have a pull rack lock movable between a lockedposition and an unlocked position. In the locked position, the pull racklock may engage the pull rack 120 to prevent proximal movement of thepull rack 120. In the unlocked position, the pull rack lock may bespaced from the pull rack 120, and the pull rack 120 and sealant sleeve130 may be proximally movable relative to the outer housing 112, frame114, and/or the pull rack lock to expose the sealant 2. The pull racklock may be initially provided in the locked position. Moving thedeployment actuator 170 from the locked position to the unlockedposition may also move the pull rack lock from the locked position tothe unlocked position. In the embodiment shown in FIG. 9, the pull rackactuating surface 172 on the deployment actuator 170 may also functionas the pull rack lock because the pull rack actuating surface 172contacts a proximal-facing surface of the pull rack 120 when thedeployment actuator 170 is in the locked position, thereby preventingproximal movement of the pull rack.

The device 100 may have a push rack lock 160, shown in FIGS. 4A-4C, thatis deflectable or otherwise movable between a locked position and anunlocked position. The push rack lock 160 may have a push rack engagingportion 164. In the locked position, shown in FIGS. 5A-5B, the push racklock 160 may engage the push rack 140 to prevent distal movement of thepush rack 140 and the support member 150. Specifically, the push rackengaging portion 164 of the push rack lock 160 may contact alatch-contacting surface 144 of the push rack 140. In the unlockedposition, shown in FIGS. 7A-7B, the push rack lock 160 may be spacedfrom the push rack 140 such that the push rack 140 and the supportmember 150 are distally movable relative to the push rack lock 160.

The push rack lock 160 may be initially provided in the locked positionto prevent advancement of the support member 150 in the event thatdistal forces are applied to the push rack 140 prematurely. For example,the push rack lock 160 may be in the locked position during shipping,handling, and preparation of the device 100 in advance of a procedure.The push rack lock 160 may also be in the locked position during theprocedure until the sealant 2 is at least partially exposed in thepuncture. The push rack lock 160 may be in the locked position when thedeployment actuator 170 is in both the locked and unlocked positions.Moving the deployment actuator 170 from the unlocked position to thepartially actuated position may also move the push rack lock 160 fromthe locked position to the unlocked position. The push rack lock 160 maybe in the unlocked position when the deployment actuator 170 is in thepartially actuated position.

When the push rack lock 160 is in the locked position, it may preferablyremain in the locked position upon axial movement of the push rack 140(or upon application of axial forces to the push rack 140). A push racklock unlocking feature 123, shown in FIG. 2A, may be movable relative tothe push rack 140 and the push rack lock 160 to move the push rack lock160 from the locked position to the unlocked position. Axial (andpreferably proximal) movement of the push rack lock unlocking feature123 may cause lateral movement of a portion of the push rack lock 160.Lateral movement of a portion of the push rack lock 160 may unlock thepush rack lock 160, thereby allowing axial (and preferably distal)movement of the push rack 140. In the embodiment shown in FIGS. 6A-7B,the push rack lock unlocking feature 123 is included on the pull rack120 such that proximal movement of the pull rack 120 may unlock the pushrack lock 160. When the push rack lock 160 is in the locked position,the pull rack 120 may be movable proximally relative to the push rack140 and the push rack lock 160. When the push rack lock 160 is in theunlocked position, the pull rack 120 and the push rack 140 may both beaxially movable relative to the push rack lock 160. Instead of beingincluded on the pull rack 120, the push rack lock unlocking feature 123may be included on another component, including the deployment actuator170, outer housing 112, and/or frame 114. The push rack lock 160 maymove from the locked position to the unlocked position upon actuation ofthe deployment actuator 170 and/or movement of the frame 114 relative tothe outer housing 112. The device 100 may include a feature thatprevents or limits premature movement of the push rack lock unlockingfeature 123. For example, the pull rack 120 may have a pull rack lockprovided in a locked position, the deployment actuator 170 may beprovided in a locked position, and/or the spring 101 may limit movementof the frame 114 relative to the outer housing 112.

The push rack 140 and the support member 150 may be substantiallyunbiased in the axial direction, and more specifically, may besubstantially unbiased relative to the sealant 2. Therefore, moving thepush rack lock 160 from the locked position to the unlocked positiondoes not automatically cause the push rack 140 to move distally towardthe sealant 2. The push rack 140 may be able to maintain the sameposition before and after the push rack lock 160 is unlocked, until thedeployment actuator 170 begins moving from a partially actuated positionto a fully actuated position to advance the push rack 140. After thepush rack lock 160 is moved from the locked position to the unlockedposition, further movement of the deployment actuator 170 may move thepush rack 140 distally.

The push rack lock 160 may be integrally formed with (or coupled to)various components of the device 100, including but not limited to theouter housing 112, the frame 114, the deployment actuator 170, or othercomponents of the device 100. In one embodiment shown in FIG. 4A, thepush rack lock 160 is integrally formed with the frame 114.

In the embodiment shown in FIGS. 4A-4C, the push rack lock 160 maycomprise a pull rack engaging portion 163 (shown as an arm 163 in FIGS.4A-4C) and a push rack engaging portion 164 (shown as a latch 164 nearone end of the arm 163 in FIGS. 4A-4C). The latch-contacting surface 144on the push rack 140 may be a protrusion, as shown in FIG. 3. When thepush rack lock 160 is in the locked position, as shown in FIGS. 5A-5B,the latch-contacting surface 144 of the push rack 140 may engage thelatch 164 to prevent distal movement of the push rack 140. The push racklock 160 may be deflected from the locked position to the unlockedposition. When the push rack lock 160 is in the unlocked position, asshown in FIGS. 7A-7B, the latch-contacting surface 144 of the push rack140 may be spaced or disengaged from the latch 164, allowing the pushrack 140 to move distally relative to the latch 164. To unlock the pushrack lock 160, the wall 123 on the pull rack 120 may slide along the arm163 of the push rack lock 160, which may deflect the arm 163 and causethe latch 164 to move laterally and become spaced or disengaged from thelatch-contacting surface 144 of the push rack 140. The latch 164 maycontact at least a distal-facing surface of the latch-contacting surface144 on the push rack 140. The latch 164 may also contact additionalsurfaces of the push rack 140. For example, the latch 164 may alsocontact a top-facing surface and/or a bottom-facing surface of thelatch-contacting surface 144 on the push rack 140 to further limitmovement of the latch 164 to a single direction, preferably a directionthat is substantially perpendicular to the longitudinal axis 3 of thedevice 100 (also referred to as a radial direction or a lateraldirection). In an exemplary embodiment shown in FIG. 5B, the latch 164may comprise a u-shaped groove or slot having an opening at the proximalend of the slot such that movement of the latch 164 is limited to theradial direction when the latch 164 engages the latch-contacting surface144.

During use, actuating the deployment actuator 170 may cause the pullrack 120 to move proximally and unlock the push rack lock 160. Onebenefit of the devices described herein is a gradual increase in theactuation force of the deployment actuator 170 while unlocking the pushrack lock 160. The angle θ of the arm 163 of the push rack lock 160 (seeFIG. 4B) may ensure a gradual increase in the actuation force. The angleθ of the arm 163 may be measured from a plane extending through thelongitudinal axis 3, and may be less than about 60°. In anotherembodiment, the angle θ may be less than about 45°, less than about 40°,less than about 35°, less than about 30°, less than about 25°, or lessthan about 20°. In another aspect, the angle θ of the arm 163 may bebetween about 10° and about 60°, between about 20° and about 45°,between about 25° and about 40°, between about 30° and about 40°, orbetween about 32° and about 36°. In one embodiment, the angle θ of thearm 163 of the push rack lock 160 may be about 34°.

If the angle θ of the arm 163 is too high, the user may experience asudden increase in the actuation force of the deployment actuator 170 asthe pull rack 120 moves proximally and the push rack lock 160 moves tothe unlocked position. However, if the angle θ of the arm 163 is toolow, it may not provide enough resistance to prevent prematureadvancement of the push rack 140 if a proximal force is applied to thepull rack 120. Therefore, the device may include a feature that preventsor limits premature movement of the push rack lock unlocking feature 123(as discussed above) to minimize the risk of prematurely unlocking thepush rack lock 160 without creating an excessively high actuation forceof the deployment actuator 170. For example, if the push rack lockunlocking feature 123 is provided on the pull rack 120, then the pullrack lock also limits or prevents premature movement of the push racklock unlocking feature 123. The actuation force of the deploymentactuator 170 may be between about 5N and about 40N. In another aspect,the actuation force may be between about 10 N and about 30 N, or betweenabout 15 N and about 20 N.

The device 100 may also have a feature to position the sealant 2 in thepuncture. For example, the device 100 may include an elongate member 102coupled to the frame 114. The elongate member 102, shown in FIG. 5C, mayextend along the longitudinal axis 3 of the device 100 shown in FIG. 1.The elongate member 102 may extend through the lumen 153 of the supportmember 150 and a lumen of the sealant 2. A radially-expandablepositioning element 104 (including but not limited to a balloon, wiremesh, or foot plate, for example) may be provided on a distal section ofthe elongate member 102. The proximal end of the positioning element 104may be connected to the elongate member 102, and the distal end of thepositioning element 104 may be connected to a core wire 103, as shown inFIG. 5C. The core wire 103 may extend along the longitudinal axis 3 ofthe device 100, in a lumen of the elongate member 102, and may moveaxially as the positioning element 104 moves between theradially-expanded configuration and the radially-contractedconfiguration. The positioning element 104 may be inserted into thevessel in a radially-contracted configuration. When the positioningelement 104 is in the vessel, it may be moved to a radially-expandedconfiguration and the device 100 may be withdrawn proximally until thepositioning element 104 contacts the vessel wall, which may providetactile confirmation that the device has been positioned properly. Ifthe positioning element 104 is a balloon, the balloon may be moved tothe radially-expanded configuration by inflating the balloon. Moving thepositioning element 104 to the radially-expanded configuration may alsomove the core wire 103 proximally relative to the elongate member 102.Once the positioning element 104 contacts the vessel wall, continuing toapply a proximal force to the outer housing 112 may compress the spring101, move the outer housing 112 (and the deployment actuator 170)proximally relative to the frame 114, and apply tension to the frame 114and/or elongate member 102. Moving the deployment actuator 170 relativeto the frame 114 may move the deployment actuator 170 to the unlockedposition, thereby allowing deployment of the sealant 2. After thesealant 2 is deployed, the positioning element 104 may be moved to theradially-contracted configuration and the device 100 may be withdrawnfrom the puncture. If the positioning element 104 is a balloon, theballoon may be moved to the radially-contracted configuration bydeflating the balloon.

The device 100 may also include a positioning element indicator 190,shown in FIG. 10. The positioning element indicator 190 may have a firstposition that provides a visual indication that the positioning element104 is in a radially-contracted configuration. The positioning elementindicator 190 may have a second position that provides a visualindication that the positioning element 104 is in a radially-expandedconfiguration. The positioning element indicator 190 may be coupled tothe core wire 103, such that axial movement of the core wire 103 alsomoves the positioning element indicator 190 axially between the firstand second positions.

An exemplary embodiment of the sealant 2 is shown in FIGS. 5C, 6C, 7C,and 8C, and may comprise known materials used for sealing punctures,including but not limited to collagen, freeze-dried hydrogels,non-cross-linked hydrogel precursors, chitosan, and combinationsthereof. A lumen may extend through the sealant 2. The sealant 2 may bepositioned in the distal section 132 of the sealant sleeve 130, radiallybetween the elongate member 102 and the sealant sleeve 130. For example,the elongate member 102 may extend through the lumen of the sealant 2,and the sealant sleeve 130 may surround the sealant 2. The supportmember 150 may be proximal to the sealant 2, such that a distal surfaceof the support member 150 may contact the sealant 2. FIG. 5D shows thesame device having an alternative embodiment of a sealant. The sealantof FIG. 5D may include a proximal section 2 a formed from freeze-driedhydrogel, and a distal section 2 b formed from a plurality ofnon-freeze-dried and/or non-cross-linked precursors. The distal section2 b may face or contact the positioning element 104.

FIGS. 5A-8C show an exemplary method for deploying the sealant 2 in apuncture. The device 100 may be provided in a resting configuration. Thedevice 100 is not shown in the resting configuration in FIGS. 5A-8C;however, the resting configuration is similar to the locatingconfiguration shown in FIGS. 5A-5C, except the positioning element 104may be in a radially-contracted configuration when the device is in theresting configuration. The deployment actuator 170, pull rack lockand/or push rack lock 160 may be in their respective locked positions.The pull rack actuating surface 172, shown in FIG. 9, may function as apull rack lock, and may contact a stop 122 on the pull rack 120 shown inFIG. 2A and/or may be offset from the opening 125 in the groove 121 inthe pull rack 120 to prevent proximal movement of the pull rack 120. Thepush rack lock 160 may engage the push rack 140 to prevent distalmovement of the push rack 140. The push rack 140 may be spaced ordisengaged from the deployment actuator 170. When the device 100 is inthe resting configuration, the positioning element indicator 190 may bein the first position, indicating that the positioning element 104 is ina radially-contracted configuration.

The distal end of the device 100 may be inserted into the puncture whilethe device 100 is in the resting configuration. When the positioningelement 104 is in the vessel, the positioning element 104 may be movedto the radially-expanded configuration, bringing the device to alocating configuration, shown in FIGS. 5A-5C. The positioning elementindicator 190 may move to the second position, indicating thatpositioning element 104 is in the radially-expanded configuration. Thedevice 100 may be withdrawn proximally until the expanded positioningelement 104 contacts the vessel wall.

Once the positioning element 104 contacts the vessel wall, continuing towithdraw the device 100 may move the device 100 from the locatingconfiguration to a pre-deployment configuration. In the embodiment shownin FIGS. 5B and 6B, continuing to withdraw the outer housing 112 maymove the device 100 from the locating configuration to thepre-deployment configuration by compressing the spring 101 and applyingtension to the frame 114 and/or elongate member 102. Tension may beapplied when the vessel wall applies a distal force to the frame 114 andelongate member 102 (via the positioning element 104) while the spring101 applies a proximal force to the frame 114 and elongate member 102.The deployment actuator 170 and/or the pull rack lock may move fromtheir respective locked positions to their respective unlockedpositions. The push rack lock 160 may remain in the locked position. Thedeployment actuator 170 (together with the outer housing 112) may moveproximally relative to the frame 114, pull rack 120, and push rack 140.The device 100 may include a tension indicator, which can indicate thatan appropriate amount of tension is being applied to the frame 114, andalso indicate that the device 100 is in the pre-deploymentconfiguration. An exemplary tension indicator 105, shown in FIG. 1, maycomprise a marking on the frame 114 that aligns with markings adjacent awindow in the outer housing 112 to indicate that the frame 114 is undertension, however any other appropriate tension indicator can be usedthat provides a similar function. Therefore, the device 100 in FIG. 1 isin the pre-deployment configuration because the frame 114 and/orelongate member 102 is under tension and the deployment actuator 170 hasnot been actuated.

When the device 100 is in the pre-deployment configuration, shown inFIGS. 6A-6C, the deployment actuator 170 and/or the pull rack lock maybe in their respective unlocked positions. The push rack lock 160 may bein the locked position. The pull rack actuating surface 172 of thedeployment actuator 170 may align with an opening 125 in a groove 121 inthe pull rack 120, allowing for proximal movement of the pull rack 120.The push rack 140 may be spaced from the deployment actuator 170.Compared to their respective positions when the device is in the restingand locating configurations, the outer housing 112 and deploymentactuator 170 may be positioned slightly proximally relative to the frame114, pull rack 120, and push rack 140 when the device is in thepre-deployment configuration. The position of the frame 114, pull rack120, and push rack 140 relative to one another may be substantially thesame when the device 100 is in the resting, locating, and pre-deploymentconfigurations.

The device 100 may be moved from the pre-deployment configuration to thepartially deployed configuration, preferably by moving the deploymentactuator 170 from the unlocked position to the partially actuatedposition. Moving the device 100 from the pre-deployment configuration tothe partially deployed configuration may move the pull rack 120 and thesealant sleeve 130 proximally to expose at least a portion of thesealant 2. The pull rack actuating surface 172 may move into and slidealong at least part of the groove 121 in the pull rack 120. Moving thedevice 100 from the pre-deployment configuration to the partiallydeployed configuration may move the push rack actuating surface 173 ofthe deployment actuator 170 toward the push rack 140, and may move thepush rack lock 160 from the locked position to an unlocked position. Thepush rack 140 and the support member 150 may remain substantiallystationary relative to the push rack lock 160 when the device 100 ismoved from the pre-deployment configuration to the partially deployedconfiguration. A distal surface of the support member 150 may contactthe sealant 2, such that the support member 150 prevents proximalmovement of the sealant 2 and maintains the position of the sealant 2 asthe sealant sleeve 130 is retracted, thereby exposing the sealant 2.

When the device 100 is in the partially deployed configuration, shown inFIGS. 7A-7C, the sealant sleeve 130 may be at least partially retractedand the sealant 2 may be at least partially exposed. The deploymentactuator 170 may be in the partially actuated position. The pull rackactuating surface 172 may be positioned in the groove 121 in the pullrack 120. The pull rack 120 may be positioned proximally compared to itsposition when the device 100 is in the pre-deployment configuration,such that the pull rack 120 and sealant sleeve 130 are at leastpartially retracted. The push rack lock 160 may be in an unlockedposition, such that the push rack lock 160 is spaced from the push rack140. The deployment actuator 170 may now engage the push rack 140,although the position axial position of push rack 140 relative to theframe 114 and/or push rack lock 160 may be substantially the same whenthe device 100 is in the pre-deployment configuration and the partiallydeployed configuration. Specifically, the push rack actuating surface173 of the deployment actuator 170 may contact the actuating ramp 143 onthe push rack 140.

The device 100 may then be moved from the partially deployedconfiguration to the fully deployed configuration, preferably by movingthe deployment actuator 170 from the partially actuated position to thefully actuated position. The push rack 140 may move distally and thesupport member 150 may move to a fully advanced position. Specifically,the push rack actuating surface 173 of the deployment actuator 170 mayslide along the actuating ramp 143 and move the push rack 140 distally.The pull rack 120 and sealant sleeve 130 may move proximally to thefully retracted position, or they may remain in the fully retractedposition if they were fully retracted in the partially deployedconfiguration.

When the device 100 is in the fully deployed configuration, shown inFIGS. 8A-8C, the sealant 2 may be exposed and compressed (or tamped) inthe puncture. The deployment actuator 170 may be in a fully actuatedposition. The pull rack 120 may be positioned either in the sameposition or proximal to its position when the device 100 is in apartially deployed configuration, such that the pull rack 120 andsealant sleeve 130 are retracted from the sealant 2 and the sealant 2 isexposed in the puncture. The push rack 140 may be moved distallyrelative to the frame 114 and/or push rack lock 160 compared to theirrespective positions when the device 100 is in the partially deployedconfiguration, such that the push rack 140 and support member 150 areadvanced toward the sealant 2 and the sealant 2 is tamped.

After the sealant 2 is exposed and compressed, the device 100 may bewithdrawn from the puncture. The retraction actuator 180, shown in FIGS.1 and 10, may be actuated to retract the positioning element 104,elongate member 102, and core wire 103 relative to the support member150, such that the positioning element 104 may be withdrawn through thesealant 2 while the support member 150 prevents the sealant 2 frommoving proximally. The retraction actuator 180 may cause the elongatemember 102 and core wire 103 to slide proximally. Alternatively, theretraction actuator 180 may bend or kink the elongate member 102 andcore wire 103, causing the distal ends of the elongate member 102 andcore wire 103 to move proximally.

One or more lockout mechanisms may prevent the user from prematurelydepressing the retraction actuator 180. First, the push rack 140 mayinclude a first retraction actuator locking surface 145, shown in FIG.10, that prevents the retraction actuator 180 from being actuated beforethe sealant 2 has been tamped. When the device 100 is in the resting,locating, pre-deployment, and partially deployed configurations, thefirst retraction actuator locking surface 145 may contact the retractionactuator 180 to prevent actuation of the retraction actuator 180. Whenthe push rack 140 moves distally and the device 100 is in the fullydeployed configuration, the first retraction actuator locking surface145 may be spaced from the retraction actuator 180 to allow actuation ofthe retraction actuator 180. Second, the positioning element indicator190 may include a second retraction actuator locking surface 191, alsoshown in FIG. 10. When the positioning element indicator 190 is in thesecond position and the positioning element 104 is in theradially-expanded configuration, the second retraction actuator lockingsurface 191 may contact the retraction actuator 180 to prevent actuationof the retraction actuator 180. When the positioning element indicator190 is in the first position and the positioning element 104 is in theradially-contracted configuration, the second retraction actuatorlocking surface 191 may be spaced from the retraction actuator 180 toallow actuation of the retraction actuator 180. Therefore, theretraction actuator 180 may be actuated after the sealant 2 has beentamped and the positioning element 104 has been returned to theradially-contracted configuration. Once the retraction actuator 180 hasbeen actuated and the positioning element 104 has been retracted throughthe sealant 2, the device 100 may be withdrawn from the puncture.

As used herein, the relative terms “proximal” and “distal” shall bedefined from the perspective of the closure system. Thus, proximalrefers to the direction of the handle of the closure system and distalrefers to the direction of the distal tip of the closure system. Theterm “axial” refers to a direction parallel to the longitudinal axis ofthe device. The terms “radial” and “lateral” refer to a direction lyingin a plane perpendicular to the longitudinal axis of the device. Theterms “retracting” and “withdrawing” indicate proximal movement, and theterm “advancing” indicates distal movement.

Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “tamping the sealant” include “instructing tamping ofthe sealant.”

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of theclosure system shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure. Awide variety of designs and approaches are possible. No feature,structure, or step disclosed herein is essential or indispensable.

Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, it will berecognized that any methods described herein may be practiced using anydevice suitable for performing the recited steps.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the disclosure may be embodied or carried out in a mannerthat achieves one advantage or a group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

Moreover, while illustrative embodiments have been described herein, thescope of any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. The limitations in theclaims are to be interpreted broadly based on the language employed inthe claims and not limited to the examples described in the presentspecification or during the prosecution of the application, whichexamples are to be construed as non-exclusive. Further, the actions ofthe disclosed processes and methods may be modified in any manner,including by reordering actions and/or inserting additional actionsand/or deleting actions. It is intended, therefore, that thespecification and examples be considered as illustrative only, with atrue scope and spirit being indicated by the claims and their full scopeof equivalents.

What is claimed is:
 1. A method for deploying a sealant to close apuncture, the method comprising: inserting a device into the puncture,the device comprising: a sealant; a sealant sleeve axially movablerelative to the sealant, wherein the sealant is disposed in the sealantsleeve; a pull rack coupled to a proximal section of the sealant sleeve;a support member disposed in the sealant sleeve proximal to the sealant;a push rack coupled to a proximal section of the support member; and apush rack lock provided in a locked position in which advancement of thepush rack is prevented; retracting the pull rack and the sealant sleeveto expose at least a portion of the sealant; moving the push rack lockto an unlocked position in which the push rack is advanceable; andadvancing the push rack and the support member to compress the sealant.2. The method of claim 1, wherein the push rack and the support memberare substantially unbiased relative to the sealant.
 3. The method ofclaim 1, wherein the device is able to maintain a position in which thepush rack lock is in the unlocked position and the push rack is insubstantially the same position as it was when the push rack lock was inthe locked position.
 4. The method of claim 1, wherein the devicefurther comprises a deployment actuator having an unlocked position, apartially actuated position, and a fully actuated position.
 5. Themethod of claim 4, further comprising a step of moving the deploymentactuator from the unlocked position to the partially actuated position,thereby retracting the pull rack and the sealant sleeve and moving thepush rack lock to the unlocked position.
 6. The method of claim 4,further comprising a step of moving the deployment actuator from thepartially actuated position to the fully actuated position, therebyadvancing the push rack and the support member.
 7. The method of claim1, wherein the push rack lock comprises a push rack engagement portion,and wherein moving the push rack lock to the unlocked position comprisesdisplacing the push rack engagement portion in a substantially lateraldirection until the push rack engagement portion is spaced from the pushrack.
 8. The method of claim 7, wherein the push rack lock furthercomprises an arm and wherein the push rack engagement portion isdisposed near an end of the arm, and wherein moving the push rack lockto the unlocked position comprises applying an axial force to the arm,thereby displacing the push rack engagement portion in the substantiallylateral direction.
 9. The method of claim 1, further comprising a stepof unlocking a pull rack lock before retracting the pull rack, whereinunlocking the pull rack lock allows the pull rack to move proximallyrelative to the push rack lock.
 10. The method of claim 1, whereinretracting the pull rack moves the push rack lock to the unlockedposition.
 11. The method of claim 1, wherein moving the push rack lockto the unlocked position allows the push rack to move distally relativeto the push rack lock.
 12. A system for closing a puncture, the systemcomprising: a sealant; a sealant sleeve axially moveable relative to thesealant, wherein the sealant is disposed in the sealant sleeve; a pullrack coupled to a proximal section of the sealant sleeve; a supportmember disposed in the sealant sleeve proximal to the sealant; a pushrack coupled to a proximal section of the support member; and a pushrack lock comprising an arm and a push rack engagement portion at an endof the arm, the push rack lock having a locked position in which thepush rack engagement portion contacts the push rack to prevent distalmovement of the push rack and an unlocked position in which the pushrack engagement portion is laterally spaced from the push rack to allowdistal movement of the push rack; wherein the push rack lock is moveablefrom the locked position to the unlocked position upon application of anaxial force to the arm.
 13. The system of claim 12, wherein the supportmember is substantially unbiased relative to the sealant.
 14. The systemof claim 12, further comprising a deployment actuator having an unlockedposition, a partially actuated position, and a fully actuated position.15. The system of claim 14, wherein the push rack is in substantiallythe same position when the deployment actuator is in the unlockedposition and the partially actuated position.
 16. The system of claim14, wherein the push rack is positioned distally when the deploymentactuator is in the fully actuated position compared to its position whenthe deployment actuator is in the partially actuated position.
 17. Thesystem of claim 12, wherein the system has a pre-deploymentconfiguration and a partially deployed configuration, wherein in thepre-deployment configuration, the sealant is positioned in the sealantsleeve and the push rack lock is in the locked position, and wherein inthe partially deployed configuration, the sealant sleeve is at leastpartially retracted from the sealant and the push rack lock is in theunlocked position.
 18. The system of claim 12, wherein the push racklock is moveable from the locked position to the unlocked position uponproximal movement of the pull rack.
 19. The system of claim 12, furthercomprising a pull rack lock having a locked position that preventsproximal movement of the pull rack and an unlocked position wherein thepull rack is proximally moveable.
 20. The system of claim 12, whereinthe push rack engagement portion comprises a latch.
 21. The system ofclaim 12, wherein the push rack is able to maintain the same positionwhen the push rack lock is in the locked position and the unlockedposition.
 22. The system of claim 12, further comprising an elongatemember and a positioning element on a distal portion of the elongatemember.
 23. A system for closing a puncture, the system comprising: anelongate member having a positioning element on a distal portionthereof; a sealant; a handle comprising an outer housing and an innerframe moveable relative to the outer housing; and a deployment actuatorcoupled to the outer housing, the deployment actuator having a lockedposition in which actuation of the deployment actuator is prevented andan unlocked position in which the deployment actuator is actuatable;wherein the deployment actuator is provided in the locked position andis moveable to the unlocked position upon application of tension to theelongate member.
 24. The system of claim 23, further comprising asealant sleeve, wherein the sealant is disposed in the sealant sleeveand the sealant sleeve is retractable upon actuation of the deploymentactuator.
 25. The system of claim 23, further comprising a supportmember disposed proximal to the sealant, wherein the support member isadvanceable upon actuation of the deployment actuator.
 26. The system ofclaim 23, wherein the inner frame has a groove and the deploymentactuator has a locking surface, and wherein the locking surface isoffset from the groove when the deployment actuator is in the lockedposition and the locking surface is aligned with the groove when thedeployment actuator is in the unlocked position.
 27. The system of claim26, wherein the locking surface is axially moveable relative to thegroove upon application of tension to the elongate member.
 28. Thesystem of claim 23, further comprising a spring configured to bias theouter housing and the deployment actuator distally relative to the innerframe, and wherein the spring is compressible upon application oftension to the elongate member to allow proximal movement of thedeployment actuator relative to the inner frame.
 29. A method fordeploying a sealant to close a puncture, the method comprising:inserting a distal end of a device into a vessel, the device comprising:an elongate member having an expandable positioning element on a distalportion thereof; a sealant provided on the elongate member proximal tothe expandable positioning element; and a deployment actuator fordeploying the sealant, the deployment actuator provided in a lockedposition in which the deployment actuator cannot be actuated; expandingthe expandable positioning element inside the vessel; withdrawing thedevice until the expandable positioning element contacts a wall of thevessel; continuing to withdraw the device with the expandablepositioning element contacting the wall of the vessel, thereby applyingtension to the elongate member and moving the deployment actuator to anunlocked position in which the deployment actuator is able to beactuated; and actuating the deployment actuator, thereby deploying thesealant.
 30. The method of claim 29, wherein deploying the sealantcomprises at least one of exposing the sealant and tamping the sealant.31. The method of claim 29, wherein the device further comprises anouter handle coupled to the deployment actuator and an inner frame, andwherein moving the deployment actuator to the unlocked positioncomprises moving the deployment actuator relative to the inner frame.32. The method of claim 31, wherein a biasing force biases thedeployment actuator and the outer handle distally relative to the innerframe, and wherein applying tension to the elongate member overcomes thebiasing force and causes the deployment actuator and the outer handle tomove proximally relative to the inner frame.